Female Genital FistulaNCT04748653

Fistula Reintegration Pilot

A study testing Multi-component reintegration intervention in people with Female Genital Fistula and Urinary Incontinence, run by University of California, San Francisco at 1 site in Uganda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Female Genital Fistula, Urinary Incontinence
What is being tested?: Multi-component reintegration intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUganda
Study dates: 1 Aug 2021to 14 Sep 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Undergoing surgery for female genital fistula
Age 18 or above, or emancipated minor per Ugandan law

Who cannot join

No further criteria

Trial locations and contacts

1 site in 1 country.

Uganda1 site

Mulago Specialized Women's and Children's Hospital
Kampala

Other trials in Uganda

About this study

Official title: Comprehensive Reintegration Assistance for Women With Obstetric Fistula

This is a pilot study to test the feasibility and acceptability of a multi-component facility-based intervention designed to be provided adjunct to genital fistula surgery incorporating: health education, psychosocial counseling, physiotherapy, and economic investment. We will include a total of 30 women in the study, and follow them for 6-months using a mixed-methods strategy for feasibility and acceptability assessment.

Conditions: Female Genital Fistula, Urinary Incontinence
Being tested: Multi-component reintegration intervention
Medical subject headings: Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multi-component reintegration interventionBehavioural
The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment.

Study groups in NCT04748653
Study group	Role	What they receive
Multi-component reintegration intervention	Experimental	There is one arm for the feasibility and acceptability study - all intervention participants will receive the intervention: health education, psychosocial counseling, physiotherapy, and economic investment. Receives: Behavioral: Multi-component reintegration intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Planned Intervention Sessions That Were Delivered
Number of planned intervention session over the total number of planned interention sessions
Measured: 6 weeks
Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Overall Experience With the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants.
Number of participants reporting to be "satisfied" or "very satisfied" about their overall experience participating in the intervention on a five-point Likert scale at six weeks over the total number of participants.
Measured: 6 weeks

Secondary outcomes (5)

Change in Reintegration Score
Mean change in reintegration score from pre-intervention (baseline) to post (6 months) on the post-fistula repair reintegration instrument (range 0-100, higher indicating better)
Measured: Baseline and 6 months
Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience With the Health Education Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants
Number of participants reporting to be "satisfied" or "very satisfied" about their experience participating in the health education component of the intervention on a five-point Likert scale at six weeks over the total number of participants.
Measured: 6 weeks
Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience Participating in the Psychosocial Counseling Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Participants.
Number of participants reporting to be "satisfied" or "very satisfied" about their experience participating in the psychosocial counseling component of the intervention on a five-point Likert scale at six weeks over the total number of participants.
Measured: 6 weeks
Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience With the Physiotherapy Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants.
Number of participants reporting to be "satisfied" or "very satisfied" about their experience with the physiotherapy component of the intervention on a five-point Likert scale at six weeks over the total number of intervention participants.
Measured: 6 weeks
Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience With the Economic Empowerment Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants
Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience With the Economic Empowerment Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202114 Sep 2022

First posted10 Feb 2021
Study start1 Aug 2021
Primary completion14 Sep 2022
Study completion14 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Female Genital FistulaStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Model description: The intervention incorporates 15 health education sessions, 6 psychosocial counseling sessions, 15 physiotherapy sessions, and an economic investment.
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04748653
Sponsor's protocol ID: P0527552
Other IDs: R00HD086232
Status last verified: May 2025
First submitted: 5 Feb 2021
Last updated: 22 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Cancer
Recurrent Gynecologic Cancer, Recurrent Uterine Cancer
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Active, not recruitingObservational study
Adverse Outcomes Following Female Genital Fistula Repair
Female Genital Fistula, Incontinence
Recruiting
Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management
Obstetric Fistula, Fistula
Recruiting
Effect of Caudal Block on Urethrocutaneous Fistula After Distal Hypospadias Repair
Hypospadias, Caudal Block

All Female Genital Fistula trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comprehensive Reintegration Assistance for Women With Obstetric Fistula
ClinicalTrials.gov ID: NCT04748653
Acronym / sponsor ID: P0527552
Conditions: Female Genital Fistula, Urinary Incontinence
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Makerere University, Mama, LLC, Mulago Hospital, Uganda
Study start: 1 Aug 2021 (actual)
Primary completion: 14 Sep 2022 (actual)
Study completion: 14 Sep 2022 (actual)
First posted: 10 Feb 2021 (actual)
Results: Posted 22 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The intervention incorporates 15 health education sessions, 6 psychosocial counseling sessions, 15 physiotherapy sessions, and an economic investment.

Arm	Type	Receives
Multi-component reintegration intervention	Experimental	Behavioral: Multi-component reintegration interventionThere is one arm for the feasibility and acceptability study - all intervention participants will receive the intervention: health education, psychosocial counseling, physiotherapy, and economic investment.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Undergoing surgery for female genital fistula
Age 18 or above, or emancipated minor per Ugandan law

Key exclusion criteria (1 listed)

No further criteria

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Multi-component reintegration interventionThe intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment.	Behavioural	Multi-component reintegration intervention

Primary outcome

Percentage of Planned Intervention Sessions That Were Delivered
Time frame: 6 weeks
Number of planned intervention session over the total number of planned interention sessions
Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Overall Experience With the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants.
Time frame: 6 weeks
Number of participants reporting to be "satisfied" or "very satisfied" about their overall experience participating in the intervention on a five-point Likert scale at six weeks over the total number of participants.

5 secondary outcomes

Change in Reintegration Score
Time frame: Baseline and 6 months
Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience With the Health Education Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants
Time frame: 6 weeks
Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience Participating in the Psychosocial Counseling Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Participants.
Time frame: 6 weeks
Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience With the Physiotherapy Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants.
Time frame: 6 weeks
Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience With the Economic Empowerment Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants
Time frame: 6 weeks

Results and safety

Results posted to the registry on 22 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Multi-component Reintegration Intervention	12	12

Primary outcome: Percentage of Planned Intervention Sessions That Were Delivered

Time frame: 6 weeks. Median (Inter-Quartile Range). Unit: percentage of planned sessions

Measure	Multi-component Reintegration Intervention n = 12
Value	96.2 (95 to 97.5)

Primary outcome: Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Overall Experience With the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants.

Time frame: 6 weeks. Count of participants. Unit: Participants

Measure	Multi-component Reintegration Intervention n = 12
Value	12

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Multi-component Reintegration Intervention	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Female Genital Fistula

RecruitingObservational study
Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Cancer
Recurrent Gynecologic Cancer, Recurrent Uterine Cancer
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Active, not recruitingObservational study
Adverse Outcomes Following Female Genital Fistula Repair
Female Genital Fistula, Incontinence
Recruiting
Effectiveness and Acceptability of Insertable Devices for Obstetric Fistula Management
Obstetric Fistula, Fistula
Recruiting
Effect of Caudal Block on Urethrocutaneous Fistula After Distal Hypospadias Repair
Hypospadias, Caudal Block

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alison El Ayadi, ScD, MPH principal investigator

University of California, San Francisco

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Multi-component reintegration intervention in people with Female Genital Fistula and Urinary Incontinence, run by University of California, San Francisco at 1 site in Uganda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Planned Intervention Sessions That Were Delivered (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04748653.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.